Joseph Rolley

Dr Vickie R. Driver is System Wide Medical Director of the Wound Care and Hyperbaric Centers at INOVA Healthcare in the DC Metropolitan area and is Professor, University of Virginia, School of Medicine. She is also Fellow, Royal College of Physicians and Surgeons-Glasgow, PM and Inaugural Fellow, Assoc for the Advancement of Wound Care, FAAWC. Dr Driver has accepted the position as Chair, Board of Directors for the Wound Care Collaborative Community, an important collaboration with the FDA, CMS and the NIH and received a prestigious honor of receiving The Robert A. Warriner III, MD Memorial Award. She is Board Certified with American Board of Podiatric Surgeons and is a Fellow at the American College of Foot and Ankle Surgeons, licensed in VA, MA, and RI. Her career has a special emphasis on wound healing and limb preservation, and she is proud to be an outspoken ambassador for improving care to patients that face

Joseph Rolley is Principal at JTR Business Consulting, LLC located in Doylestown, Pennsylvania providing market access and business consulting services to the medical technology industry. Joe has over 40 years of experience in the medical device industry spanning sales, marketing, business development, reimbursement, government affairs and health policy. Prior to his current consulting role, he was Vice President, Market Access and Professional Education at Integra Life Sciences in Princeton, New Jersey. At Integra, he led teams that created and implemented market access and health economic strategies that opened government and commercial payer access for new and in-licensed regenerative technologies. He also led the company’s surgeon education and cadaver lab program. Prior to Integra, he served for 30 years in business roles of increasing responsibility at Bristol-Myers Squibb and Convatec.

He has been actively involved in industry and professional associations throughout his career. He currently serves the Wound Care Collaborative Community as Treasurer and Board Member. He represented the wound care industry at the AdvaMed trade association where he co-led the establishment of the Wound Healing & Tissue Regeneration Sector and served as working group chair for over 15 years. He also chaired the Corporate Advisory Council of the National Pressure Injury Advisory Panel (NPIAP) and was the 2009 recipient of the Thomas Stewart Founder’s Award for his public policy support.

Mr. Rolley holds a B.S. degree in Biochemistry and a M.S. degree in Industrial Administration, both from Purdue University. He and his wife, Theresa, reside in Doylestown, Pennsylvania, USA.

Dr Yu-Chieh Chiu is an assistant director at the FDA's Center for Devices and Radiological Health (CDRH). Joining the agency in 2016, he has served in CDRH/OPEQ/OHT4 since August 2023. Dr Chiu oversees medical device reviews with a focus on wound care products, having reviewed and signed off on over 500 premarket and postmarket submissions while leading the development of wound device guidance documents and participating in interagency projects. He serves as the Wound Care Collaborative Community liaison, where he contributes his expertise to advance wound care device regulation and foster cross-functional collaboration across stakeholders. His roles at FDA have included Team Lead for OHT1/THT1A2 (October 2021 - August 2023) and Lead Reviewer for OHT4/TH4B4 (January 2018 - October 2021), as well as several acting leadership positions across different offices. 

Throughout his FDA career, Dr Chiu has reviewed over 700 submissions across diverse device categories, including wound care devices, plastic surgery devices (dermal fillers and microneedling devices), ophthalmic devices (contact lenses and dry eye devices), and orthopedic devices. He is recognized as a biocompatibility expert across CDRH, providing consultation on biocompatibility issues for various device types and training reviewers to conduct independent assessments. Dr Chiu has contributed to regulatory policy development, leading the drafting of negative pressure wound therapy guidance and participating in FRO preamble preparation/finalization, while also serving as a technical expert for ASTM F04.43 Cells and Tissue Engineering Constructs. Dr Chiu is knowledgeable about FDA regulations, including the FD&C Act, 21st Century Cures Act, and device-specific guidance documents. His combination of scientific expertise, regulatory knowledge, and proven leadership in supervising review teams and mentoring staff has made him an invaluable contributor to FDA's mission of protecting public health through effective medical device regulation. 

Dheerendra Kommala, MD, is chief medical officer at ECRI, responsible for ECRI’s Medical Office. He joined ECRI in 2019 as Chief Strategy Officer responsible for setting the organization’s strategic direction. 

Dr Kommala brings more than 25 years of experience as an academic clinician, researcher, and chief medical officer. He successfully introduced new products and services to markets throughout the world by working collaboratively with major health systems, industry leaders, clinicians, and patients. Throughout his career, he has been a vocal advocate for patient safety and a visionary leader managing large teams. 

Prior to joining ECRI, Dr Kommala was global vice president of medical affairs for Baxter Healthcare. Previous experience included working as chief medical officer/global vice president of medical affairs for ConvaTec and as associate medical director of Global Pharmaceutical Research for Renal Care, Abbott Laboratories. 

Dr Kommala received his initial medical training in India and completed a fellowship in nephrology at the University of Missouri, Columbia School of Medicine.

Cristin Taylor is a senior medical affairs leader with extensive experience advancing innovation, clinical strategy, and evidence generation in advanced wound care. She is currently the senior director of Medical Affairs for Advanced Wound Care at Convatec, where she supports the development and clinical integration of technologies addressing complex and chronic wounds. 

Dr Taylor brings a multidisciplinary background spanning industry, clinical science, and translational research, with prior leadership roles in clinical and medical affairs at Gelmetix and as founder of Alclinix LLC. Her experience also includes senior clinical science and advisory positions at PathAI, Beckman Coulter Diagnostics, and Smith & Nephew as well as earlier clinical and academic appointments at leading health care institutions. 

She holds a Doctor of Physical Therapy from the University of Miami, a Master of Science in Health Sciences from The George Washington University, and a Certificate in Finance for Senior Executives from Harvard Business School Executive Education. Her work focuses on bridging clinical evidence, regulatory strategy, and commercialization to accelerate meaningful innovation in wound care. 

Dev is a plastic and reconstructive surgeon with 5+ years of FDA regulatory experience and specialized expertise in wound healing product development, combining clinical wound care expertise with comprehensive regulatory oversight of chronic wound therapeutics across the complete development lifecycle.

As FDA Medical Officer in CDER Division of Dermatology from 2020 - 2025 and Chair of the FDA Inter-Center Wound Healing Working Group, Dev led cross-agency regulatory strategy for wound healing products and organized a landmark 2022 FDA Wound Healing Scientific Workshop with 330+ stakeholders. He provided scientific oversight for innovative wound therapeutics from Pre-IND through NDA/BLA approval, with expertise in clinical trial design, endpoint validation, real-world evidence integration, and regulatory pathways for wound healing therapeutic indications. In addition, he served as CDER representative to the Wound Care Collaborative Community (WCCC). His clinical background includes managing patients with nonhealing chronic wounds and performing complex wound reconstruction surgeries, providing real-world understanding of treatment challenges and unmet medical needs.

In his new role as Senior Medical Director, Clinical Development at Oruka Therapeutics he is responsible for execution and operational oversight of clinical trials for psoriasis and hidradenitis suppurativa, ensuring high-quality data generation to support the safety and efficacy of pipeline products.

Dr Rachana Visaria is the Acting Director of the Division of Plastic and Reconstructive Surgery Devices within the Office of Surgical and Infection Control Devices (OHT4) at the FDA's Center for Devices and Radiological Health (CDRH). She holds a PhD in Bioengineering and is a Regulatory Affairs Certified (RAC) professional with over 10 years of experience in regulatory science, policy development, and total product lifecycle (TPLC) oversight. Her regulatory expertise spans diagnostic, monitoring, screening, and therapeutic products, including wound care devices, surgical implants, respiratory devices, digital health technologies, and neurostimulators. She has directed the review and evaluation of complex regulatory submissions including PMAs, De Novos, breakthrough device designations, and Medical Device Development Tool (MDDT) requests. She has authored numerous peer-reviewed publications and book chapters, including recent work on digital health regulation, and serves as FDA's primary liaison to several international standards working groups. Her commitment to regulatory excellence, stakeholder collaboration, and patient-centered innovation has been recognized through multiple CDRH awards. 

Dr Alper is a podiatric physician, recently retired from working in the private solo practice he started 36 years ago in Belmont, MA. Specializing in preventative diabetic foot care, he is now Emeritus Surgical staff at Mt. Auburn Hospital (a Harvard teaching hospital). He currently is a member of the Leadership Board of the American Diabetes Assn. (ADA) in New England, having served as president for over 20 years, and is an elected member of the Board of Trustees of the American Podiatric Medical Association (APMA). He also had the honor of serving as chair of the Belmont (MA) Board of Health for 30 years, where he was seen as a leader in Public Health for the community. This led to his appointment by the Governor to his current position on the Massachusetts Association of Health Boards (MAHB), allowing him to continue his public health work. 

Since his retirement, Dr Alper has spent much of his time in the world of limb amputation prevention, using his connections in the diabetes, podiatry, and vascular worlds to create collaborations between medical societies. He currently serves on the Board of the Wound Care Collaborative Community (WCCC), The Way To My Heart (patient advocacy), the Foot Ankle Health section of the American Public Health Assn. (APHA), and he is in the process of forming a collaborative committee with the Society of Interventional Radiologists and the APMA. 

In addition to lecturing at Northeastern University’s PA program, Dr Alper is a noted speaker and writer on a variety of podiatric topics for the lay public, including articles published in Prevention, Health Journal, and Walking magazines and various webinars and podcasts. When not in the world of feet, you can find him in his blacksmith’s forge or with his wife Pam and three wonderful children – Megan, Adam, and Brian – and his wonderful Shih Tzu, Gizmo.

Matthew J. Davis, BSN, RN, CWON, CFCN, is a board-certified wound and ostomy nurse and health care leader dedicated to advancing ethical, evidence-based wound care. He currently serves as senior director of Medical Affairs at Surgenex. He is currently the president of the Association for the Advancement of Wound Care (AAWC). Matthew’s career spans hospital systems, wound clinics, and industry clinical engagement, where he focuses on translating innovation into real-world clinical impact. Known for building compliant, patient-centered programs, he champions access to advanced therapies, clinician education, and data-driven outcomes to improve healing for complex wound populations. 

Dr. Chandan K. Sen, PhD, FNAI, is a distinguished figure in regenerative medicine and wound care. He is an elected Fellow of the National Academy of Inventors. Dr. Sen is the inaugural Bartley Griffith Chair in Regenerative Medicine at the Dept. of Surgery and directs the McGowan Institute for Regenerative Medicine at the University of Pittsburgh. He also serves as the Associate Vice Chancellor for Life Sciences Innovation and Commercialization at the University of Pittsburgh. Dr. Sen's leadership focuses on advancing health care research vital to Pittsburgh's future, fostering collaborations with local and national partners, and facilitating the translation of scientific discoveries into practical applications for patients. With a career spanning over three decades, Dr. Sen's research has been instrumental in developing innovative solutions for tissue injury, regeneration, and infection management. Notable breakthroughs include pioneering technologies such as tissue nanotransfection and electroceutical infection management. He is the current vice-chair and chair-elect of the national NIH-funded Diabetic Foot Consortium. Dr. Sen's contributions have earned prestigious recognitions, including the 2018 Edison Award for Innovation and the 2016 Frost & Sullivan Award for New Product Innovation. With an extensive publication record, Dr. Sen’s work has been cited over 55000 times in the literature with current H-index 119.

Dr Vickie R. Driver is System Wide Medical Director of the Wound Care and Hyperbaric Centers at INOVA Healthcare in the DC Metropolitan area and is Professor, University of Virginia, School of Medicine. She is also Fellow, Royal College of Physicians and Surgeons-Glasgow, PM and Inaugural Fellow, Assoc for the Advancement of Wound Care, FAAWC. Dr Driver has accepted the position as Chair, Board of Directors for the Wound Care Collaborative Community, an important collaboration with the FDA, CMS and the NIH and received a prestigious honor of receiving The Robert A. Warriner III, MD Memorial Award. She is Board Certified with American Board of Podiatric Surgeons and is a Fellow at the American College of Foot and Ankle Surgeons, licensed in VA, MA, and RI. Her career has a special emphasis on wound healing and limb preservation, and she is proud to be an outspoken ambassador for improving care to patients that face

Joseph Rolley is Principal at JTR Business Consulting, LLC located in Doylestown, Pennsylvania providing market access and business consulting services to the medical technology industry. Joe has over 40 years of experience in the medical device industry spanning sales, marketing, business development, reimbursement, government affairs and health policy. Prior to his current consulting role, he was Vice President, Market Access and Professional Education at Integra Life Sciences in Princeton, New Jersey. At Integra, he led teams that created and implemented market access and health economic strategies that opened government and commercial payer access for new and in-licensed regenerative technologies. He also led the company’s surgeon education and cadaver lab program. Prior to Integra, he served for 30 years in business roles of increasing responsibility at Bristol-Myers Squibb and Convatec.

He has been actively involved in industry and professional associations throughout his career. He currently serves the Wound Care Collaborative Community as Treasurer and Board Member. He represented the wound care industry at the AdvaMed trade association where he co-led the establishment of the Wound Healing & Tissue Regeneration Sector and served as working group chair for over 15 years. He also chaired the Corporate Advisory Council of the National Pressure Injury Advisory Panel (NPIAP) and was the 2009 recipient of the Thomas Stewart Founder’s Award for his public policy support.

Mr. Rolley holds a B.S. degree in Biochemistry and a M.S. degree in Industrial Administration, both from Purdue University. He and his wife, Theresa, reside in Doylestown, Pennsylvania, USA.

Dr Vickie R. Driver is System Wide Medical Director of the Wound Care and Hyperbaric Centers at INOVA Healthcare in the DC Metropolitan area and is Professor, University of Virginia, School of Medicine. She is also Fellow, Royal College of Physicians and Surgeons-Glasgow, PM and Inaugural Fellow, Assoc for the Advancement of Wound Care, FAAWC. Dr Driver has accepted the position as Chair, Board of Directors for the Wound Care Collaborative Community, an important collaboration with the FDA, CMS and the NIH and received a prestigious honor of receiving The Robert A. Warriner III, MD Memorial Award. She is Board Certified with American Board of Podiatric Surgeons and is a Fellow at the American College of Foot and Ankle Surgeons, licensed in VA, MA, and RI. Her career has a special emphasis on wound healing and limb preservation, and she is proud to be an outspoken ambassador for improving care to patients that face

Joseph Rolley is Principal at JTR Business Consulting, LLC located in Doylestown, Pennsylvania providing market access and business consulting services to the medical technology industry. Joe has over 40 years of experience in the medical device industry spanning sales, marketing, business development, reimbursement, government affairs and health policy. Prior to his current consulting role, he was Vice President, Market Access and Professional Education at Integra Life Sciences in Princeton, New Jersey. At Integra, he led teams that created and implemented market access and health economic strategies that opened government and commercial payer access for new and in-licensed regenerative technologies. He also led the company’s surgeon education and cadaver lab program. Prior to Integra, he served for 30 years in business roles of increasing responsibility at Bristol-Myers Squibb and Convatec.

He has been actively involved in industry and professional associations throughout his career. He currently serves the Wound Care Collaborative Community as Treasurer and Board Member. He represented the wound care industry at the AdvaMed trade association where he co-led the establishment of the Wound Healing & Tissue Regeneration Sector and served as working group chair for over 15 years. He also chaired the Corporate Advisory Council of the National Pressure Injury Advisory Panel (NPIAP) and was the 2009 recipient of the Thomas Stewart Founder’s Award for his public policy support.

Mr. Rolley holds a B.S. degree in Biochemistry and a M.S. degree in Industrial Administration, both from Purdue University. He and his wife, Theresa, reside in Doylestown, Pennsylvania, USA.